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NCT00037518 Clinical Trial

A Study of an Investigational Medication for Severe Primary Hyperparathyroidism or Parathyroid Cancer

Hyperparathyroidism Clinical Trial

Official title:
An Assessment of the Calcimimetic Agent AMG 073 for the Treatment of Subjects With Parathyroid Carcinoma or Intractable Primary Hyperparathyroidism.

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00037518
Other study ID # 20000204
Secondary ID
Status Completed
Phase Phase 4
First received May 17, 2002
Last updated May 6, 2013
Start date April 2001

Study information
Verified date May 2013
Source Amgen
Contact n/a
Is FDA regulated No
Health authority United States: Food and Drug Administration
Study type Interventional

Clinical Trial Summary

This study will assess an investigational medication for patients with severe primary hyperparathyroidism or parathyroid cancer.

Recruitment information / eligibility
Status Completed
Enrollment 46
Est. completion date
Est. primary completion date
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
Eligibility - Patients must have parathyroid carcinoma or severe primary hyperparathyroidism; * Abnormally elevated calcium levels above 12.5 mg/dL; * Not be pregnant or nursing; * Not have had any type of cancer other than parathyroid carcinoma within the last 5 years.

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

Intervention

Drug:
• AMG 073

Locations
Country Name City State
n/a

Sponsors (1)
Lead Sponsor Collaborator
Amgen

References & Publications (2)

Marcocci C, Chanson P, Shoback D, Bilezikian J, Fernandez-Cruz L, Orgiazzi J, Henzen C, Cheng S, Sterling LR, Lu J, Peacock M. Cinacalcet reduces serum calcium concentrations in patients with intractable primary hyperparathyroidism. J Clin Endocrinol Meta — View Citation

Silverberg SJ, Rubin MR, Faiman C, Peacock M, Shoback DM, Smallridge RC, Schwanauer LE, Olson KA, Klassen P, Bilezikian JP. Cinacalcet hydrochloride reduces the serum calcium concentration in inoperable parathyroid carcinoma. J Clin Endocrinol Metab. 2007 — View Citation

Outcome
Type Measure Description Time frame Safety issue
Primary Changes in serum calcium and PTH
Secondary Safety and tolerability of cinacalcet
See also
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